Clearance Summary
Healgen URS Test Strips received FDA 510(k) clearance under submission number K231045, sponsored by Healgen Scientific,, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2023-06-16.
- Submission: K231045
- Applicant / Sponsor: Healgen Scientific,, LLC
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.7675
- Decision date: 2023-06-16
Classification & Regulation
This clearance is catalogued under FDA product code LJX and 21 CFR 864.7675, within the Hematology review panel as a Class I device.